††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS
311.565(1)(a) authorizes the board to promulgate administrative regulations to
regulate the conduct of its licenses. KRS 218A.205(3)(a) requires the board to
establish mandatory prescribing and dispensing standards related to controlled
substances. This administrative regulation establishes the professional
standards for prescribing and dispensing controlled substances.

††††† Section 1. Applicability. (1) A physician
who is authorized to prescribe or dispense a controlled substance shall comply
with the standards of acceptable and prevailing medical practice for
prescribing and dispensing a controlled substance established in this
administrative regulation.

††††† (2) The professional standards established
in this administrative regulation shall not apply to a physician prescribing or
dispensing a controlled substance:

††††† (a) To a patient as part of the patientís
hospice or end-of-life treatment;

††††† (b) To a patient admitted to a licensed
hospital as an inpatient, outpatient, or observation patient, during and as
part of a normal and expected part of the patientís course of care at that
hospital;

††††† (c) To a patient for the treatment of
pain associated with cancer or with the treatment of cancer;

††††† (d) To a patient who is a registered
resident of a long-term-care facility as defined in KRS 216.510;

††††† (e) During the effective period of any
period of disaster or mass casualties which has a direct impact upon the
physicianís practice;

††††† (f) In a single dose[prescribed or
dispensed] to relieve the anxiety, pain, or discomfort experienced by that
patient submitting to a diagnostic test or procedure; [or]

††††† (g) That has been classified as a
Schedule V controlled substance;

††††† (h) That is a Schedule II controlled
substance as part of a narcotic treatment program licensed by the Cabinet for
Health and Family Services; or

††††† (i) That is a Schedule II controlled
substance immediately prior to, during, or within the fourteen (14) days
following a major surgery or significant trauma, being any operative or
invasive procedure or a delivery, and the usage does not extend beyond fourteen
(14) days.

††††† Section 2. Professional Standards for
Documentation of Patient Assessment, Education, Treatment Agreement and
Informed Consent, Action Plans, Outcomes and Monitoring. (1) Each physician
prescribing or dispensing a controlled substance shall obtain and document all
relevant information in a patientís medical record in a legible manner and in
sufficient detail to enable the board to determine whether the physician is
conforming to professional standards for prescribing or dispensing controlled
substances and other relevant professional standards.

††††† (2) If a physician is unable to conform
to professional standards for prescribing or dispensing controlled substances
due to circumstances beyond the physicianís control, or the physician makes a
professional determination that it is not appropriate to comply with a specific
standard, based upon the individual facts applicable to a specific patientís diagnosis
and treatment, the physician shall document those circumstances in the
patientís record and only prescribe or dispense a controlled substance to the
patient if the patient record appropriately justifies the prescribing or
dispensing of a controlled substance under the circumstances.

††††† Section 3. Professional Standards for the
Prescribing or Dispensing of Controlled Substances for the Treatment of Pain
and Related Symptoms Associated with a Primary Medical Complaint. Prior to the
initial prescribing or dispensing of any controlled substance for pain or other
symptoms associated with the same primary medical complaint, the first
physician prescribing or dispensing a controlled substance shall:

††††† (1) Obtain an appropriate medical history
relevant to the medical complaint, including a history of present illness, and:

††††† (a) If the complaint does not relate to a
psychiatric condition, conduct a physical examination of the patient relevant
to the medical complaint and related symptoms and document the information in
the patientís medical record; or

††††† (b) If the complaint relates to a
psychiatric condition, perform, or have performed by a psychiatrist or other
designated mental health provider, an evaluation appropriate to the presenting
complaint and document the relevant findings;

††††† (2) Obtain and review a KASPER report for
that patient for the twelve (12) month period immediately preceding the patient
encounter, and appropriately utilize that information in the evaluation and
treatment of the patient;

††††† (3) After examining the benefits and
risks of prescribing or dispensing a controlled substance to the patient,
including nontreatment or other treatment, make a deliberate decision that it
is medically appropriate to prescribe or dispense the controlled substance in the
amount specified;

††††† (4) Only prescribe Schedule II
controlled substances in accordance with the standards established in Section 9
of this administrative regulation;

††††† (5) Not prescribe or dispense a
long-acting or controlled-release opioid (e.g. OxyContin, fentanyl patches, or
methadone) for acute pain that is not directly related to and close in time to
a specific surgical procedure;

††††† (6)[(5)] Explain to the
patient that a controlled substance used to treat an acute medical complaint is
for time-limited use, and that the patient should discontinue the use of the
controlled substance when the condition requiring the controlled substance use
has resolved; and

††††† (7)[(6)] Explain to the
patient how to safely use and properly dispose of any unused controlled substance.

††††† Section 4. Professional Standards for
Commencing Long Term Use of Prescribing or Dispensing of Controlled Substances
for the Treatment of Pain and Related Symptoms Associated with a Primary
Medical Complaint. (1) Before a physician commences to prescribe or dispense
any controlled substance to a patient sixteen (16) years or older for pain or
other symptoms associated with the same primary medical complaint for a total
period of longer than three (3) months, the physician shall comply with the mandatory
professional standards established in subsection (2) of this section. These
standards may be accomplished by different licensed practitioners in a single
group practice at the direction of or on behalf of the prescribing physician
if:

††††† (a) Each practitioner involved has lawful
access to the patientís medical record;

††††† (b) There is compliance with all
applicable standards; and

††††† (c) Each practitioner performing an
action to meet the required standards is acting within the practitionerís legal
scope of practice.

††††† (2)(a) The physician shall obtain the
following information from the patient and record all relevant information in
the patientís medical record:

††††† 1. History of present illness;

††††† 2. Past medical history;

††††† 3. History of substance use and any prior
treatment for that use by the patient, and history of substance abuse by first
degree relatives of the patient;

††††† 4. Past family history of relevant
illnesses and treatment; and

††††† 5. Psychosocial history.

††††† (b) The physician shall conduct an
appropriate physical examination of the patient sufficient to support the
medical indications for prescribing or dispensing a controlled substance on a
long-term basis.

††††† (d) If a specific or specialized
evaluation is necessary for the formulation of a working diagnosis or treatment
plan, the physician shall only continue the use of a controlled substance after
determining that continued use of the controlled substance is safe and
medically appropriate in the absence of that information.

††††† (e) If the physician determines that the
patient has previously received medical treatment for the presenting medical
complaint or related symptoms and that review of the prior treatment records is
necessary to justify long-term prescribing of a controlled substance, the
physician shall obtain those prior medical records and incorporate the information
therein into the evaluation and treatment of the patient.

††††† (f)1. Based upon consideration of all
information available, the physician shall promptly formulate and document a
working diagnosis of the source of the patientís medical complaint and related
symptoms without simply describing or listing the related symptoms.

††††† 2. If the physician is unable, despite
best efforts, to formulate a working diagnosis, the physician shall consider
the usefulness of additional information, such as a specialized evaluation or
assessment, referral to an appropriate specialist, and the usefulness of
further observation and evaluation, before attempting again to formulate a
working diagnosis.

††††† 3. If the physician is unable to
formulate a working diagnosis, despite the use of an appropriate specialized
evaluation or assessment, the physician shall only prescribe long term use of a
controlled substance after establishing that its use at a specific level is
medically indicated and appropriate.

††††† (g)1. To the extent that functional
improvement is medically expected based upon the patientís condition, the
physician shall formulate an appropriate treatment plan.

††††† 2. The treatment plan shall include
specific and verifiable goals of treatment, with a schedule for periodic
evaluations.

††††† (h)1. The physician shall utilize
appropriate screening tools to screen each patient to determine if the patient:

††††† a. Is presently suffering from another
medical condition which may impact the prescribing or dispensing of a
controlled substance; or

††††† b. Presents a significant risk for
illegal diversion of a controlled substance.

††††† 2. If, after screening, the physician
determines that there is a reasonable likelihood that the patient suffers from
substance abuse or dependence, or a psychiatric or psychological condition, the
physician shall take the necessary actions to facilitate a referral to an
appropriate treatment program or provider. The physician shall appropriately
incorporate the information from the treatment program or provider into the
evaluation and treatment of the patient.

††††† 3. If, after screening, the physician
determines that there is a risk that the patient may illegally divert a
controlled substance, but determines to continue long term prescribing of the
controlled substance, the physician shall use a prescribing agreement that
meets professional standards. The prescribing agreement and informed consent
document may be combined into one (1) document.

††††† 5. If, after screening, the physician
determines that the controlled substance prescribed to the patient will be used
or is likely to be used other than medicinally or other than for an accepted
therapeutic purpose, the physician shall not prescribe any controlled substance
to that patient.

††††† (i) After explaining the risks and
benefits of long-term use of a controlled substance, the physician shall obtain
the written informed consent of the patient in a manner that meets professional
standards.

††††† (j) The physician shall initially attempt,
to the extent possible, or establish and document a previous attempt by another
physician, of a trial of noncontrolled modalities and lower doses of a
controlled substance in increasing order to treat the pain and related symptoms
associated with the primary medical complaint, before continuing with long term
prescribing of a controlled substance at a given level.

††††† Section 5. Professional Standards for
Continuing Long Term Prescribing or Dispensing of Controlled Substances for the
Treatment of Pain and Related Symptoms Associated with a Primary Medical
Complaint. (1) If a physician continues to prescribe or dispense a controlled
substance beyond three (3) months to a patient sixteen (16) years or older for
pain and related symptoms associated with the primary medical complaint, the
physician shall comply with the professional standards established in
subsection (2) of this section and, if a Schedule II controlled substance,
Section 9 of this administrative regulation. These standards may be
accomplished by different licensed practitioners in a single group practice at
the direction of or on behalf of the prescribing physician as established in
Section 4(1) of this administrative regulation.

††††† (2)(a)1. The physician shall ensure that
the patient is seen at least once a month initially for evaluation and review
of progress. The physician may determine that the patient is to be evaluated
less frequently, on a schedule determined by the physicianís professional
judgment after the physician has determined:

††††† a. The controlled substance prescribed or
dispensed has been titrated to the level appropriate and necessary to treat the
medical complaint and related symptoms;

††††† b. The controlled substance prescribed or
dispensed is not causing unacceptable side effects; and

††††† c. There is sufficient monitoring in
place to minimize the likelihood that the patient will use the controlled
substance in an improper or inappropriate manner or divert it for an improper
or inappropriate use.

††††† (b) At appropriate intervals, the physician
shall:

††††† 1. Ensure that a current history is
obtained from the patient;

††††† 2. Ensure that a focused physical
examination is considered, and performed, if appropriate; and

††††† (c) At appropriate intervals, the
physician shall evaluate the working diagnosis and treatment plan based upon
the information gained to determine whether there has been functional
improvement or any change in baseline measures. The physician shall modify the
diagnosis, treatment plan, or controlled substance therapy, as appropriate.

††††† (d) If the physician determines that the
patient presents a significant risk of diversion or improper use of a
controlled substance, the physician shall discontinue the use of the controlled
substance or justify its continued use in the patient record.

††††† (e) If the medical complaint and related
symptoms continue with no significant improvement in function despite treatment
with a controlled substance, and if improvement is medically expected, the
physician shall obtain appropriate consultative assistance to determine whether
there are undiagnosed conditions to be addressed in order to resolve the
medical complaint.

††††† (f) For a patient exhibiting symptoms
suggestive of a mood, anxiety, or psychotic disorder, the physician shall
obtain a psychiatric or psychological consultation for intervention if
appropriate.

††††† 1. Attempt to identify the trigger or
triggers for each episode;

††††† 2. Determine whether the breakthrough
pain may be adequately treated through noncontrolled treatment; and

††††† 3. If the physician determines that the
nonmedication treatments do not adequately address the triggers, and after
considering the risks and benefits, determines to add an as-needed controlled
substance to the regimen, take appropriate steps to minimize the improper or
illegal use of the additional controlled substance.

††††† (h) At least once a year, the physician
shall perform or shall ensure that the patientís primary treating physician
performs a preventive health screening and physical examination appropriate to
the patientís gender, age, and medical condition.

††††† (i)1. At least once every three (3)
months, the physician shall obtain and review a current KASPER report, for the
twelve (12) month period immediately preceding the request, and appropriately
use that information in the evaluation and treatment of the patient.

††††† 2. If the physician obtains or receives
specific information that the patient is not taking the controlled substance as
directed, is diverting a controlled substance, or is engaged in any improper or
illegal use of a controlled substance, the physician shall immediately obtain
and review a KASPER report and appropriately use the information in the
evaluation and treatment of the patient.

††††† 3. If a KASPER report discloses that the
patient is obtaining a controlled substance from another practitioner without
the physicianís knowledge and approval, in a manner that raises suspicion of
illegal diversion, the physician shall promptly notify the other practitioner
of the relevant information from the KASPER review.

††††† 4. The physician shall obtain
consultative assistance from a specialist if appropriate.

††††† (j) If appropriate, the physician shall
conduct random pill counts and appropriately use that information in the
evaluation and treatment of the patient.

††††† (k)1. During the course of long-term
prescribing or dispensing of a controlled substance, the physician shall
utilize drug screens, appropriate to the controlled substance and the patientís
condition, in a random and unannounced manner at appropriate times. If the drug
screen or other information available to the physician indicates that the
patient is noncompliant, the physician shall:

††††† a. Do a controlled taper, consistent
with subparagraph 3 of this paragraph;

††††† d. The patient is taking high-risk
regimen, including but not limited to dosages ≥50 MME/day or opioids
with benzodiazepines, without evidence of benefit.

††††† 3. The physician shall taper
controlled substances in a manner slow enough to minimize symptoms and signs of
opioid withdrawal and shall collaborate with other specialists as needed to
optimize nonopioid pain management and psychosocial support for anxiety related
to the taper.

††††† 4. A physician shall stop prescribing
or dispensing any controlled substance diverted by or from the patient or taken
less frequently than once a day.

††††† Section 6. Professional Standards for the
Prescribing and Dispensing of Controlled Substances in an Emergency Department.
In addition to complying with the standards for the initial prescribing or
dispensing of a controlled substance as established in Sections 3 and 7 of this
administrative regulation, a physician prescribing or dispensing a controlled
substance for a specific medical complaint and related symptoms to a patient in
an emergency department shall not routinely:

††††† (1) Administer an intravenous controlled
substance for the relief of acute exacerbations of chronic pain, unless
intravenous administration is the only medically appropriate means of delivery;

††††† (2) Provide a replacement prescription
for a controlled substance that was lost, destroyed, or stolen;

††††† (3) Provide a replacement dose of
methadone, suboxone, or subutex for a patient in a treatment program;

††††† (4) Prescribe a long-acting or
controlled-release controlled substance, such as OxyContin, fentanyl patches,
or methadone or a replacement dose of that medication;

††††† (5) Administer Meperidine to the patient;
or

††††† (6) Prescribe or dispense more than the
minimum amount medically necessary to treat the patientís medical condition
until the patient can be seen by the primary treating physician or another
physician, with no refills. If the controlled substance prescription exceeds
seven (7) days in length (or exceeds three (3) days if a Schedule II
controlled substance), the patient record shall justify the amount of the
controlled substance prescribed.

††††† Section 7. Professional Standards for the
Prescribing and Dispensing of Controlled Substances for the Treatment of Other
Conditions. (1) Before initially prescribing or dispensing a controlled
substance to a patient for a condition other than pain, the physician shall:

††††† (a) Obtain an appropriate medical history
relevant to the medical complaint, including a history of present illness, and:

††††† 1. If the complaint does not relate to a
psychiatric condition, conduct a physical examination of the patient relevant
to the medical complaint and related symptoms and document the information in
the patientís medical record; or

††††† 2. If the complaint relates to a
psychiatric condition, perform, or have performed by a psychiatrist or other
designated mental health provider, an evaluation appropriate to the presenting
complaint and document the relevant findings;

††††† (b) Obtain and review a KASPER report for
that patient, for the twelve (12) month period immediately preceding the
patient encounter, and appropriately utilize that information in the evaluation
and treatment of the patient;

††††† (c) After examining the benefits and
risks of prescribing or dispensing a controlled substance to the patient,
including nontreatment or other treatment, make a deliberate decision that it
is medically appropriate to prescribe or dispense the controlled substance in
the amount specified;

††††† (d) Avoid providing more controlled
substances than necessary by prescribing or dispensing only the amount of a
controlled substance needed to treat the specific medical complaint;

††††† (e) Explain to the patient that a
controlled substance used to treat an acute medical complaint is for
time-limited use, and that the patient should discontinue the use of a
controlled substance when the condition requiring the controlled substance use
has resolved; and

††††† (f) Explain to the patient how to safely
use and properly dispose of any unused controlled substance.

††††† (2) If the physician continues to
prescribe or dispense a controlled substance to a patient for the same medical
complaint and related symptoms, the physician shall fully conform to the
standards of acceptable and prevailing practice for treatment of that medical
complaint and for the use of the controlled substance.

††††† (3) If a physician receives a request
from an established patient to prescribe or dispense a limited amount of a
controlled substance to assist the patient in responding to the anxiety or
depression resulting from a nonrecurring single episode or event, the physician
shall:

††††† (a) Obtain and review a KASPER report for
that patient for the twelve (12) month period immediately preceding the patient
request and appropriately utilize the information obtained in the evaluation
and treatment of the patient;

††††† (b) Make a deliberate decision that it is
medically appropriate to prescribe or dispense the controlled substance in the
amount specified, with or without requiring a personal encounter with the
patient to obtain a more detailed history or to conduct a physical examination;
and

††††† (c) If the decision is made that it is
medically appropriate to prescribe or dispense the controlled substance,
prescribe or dispense the minimum amount of the controlled substance to
appropriately treat the situational anxiety or depression.

††††† (2) Educational materials relating to
these subjects may be found on the boardís Web site, www.kbml.ky.gov.

††††† Section 9. Additional Standards for
Prescribing or Dispensing Schedule II Controlled Substances[or Schedule III
Controlled Substances Containing Hydrocodone]. (1) In addition to the other
standards established in this administrative regulation, prior to the initial
prescribing or dispensing of a Schedule II controlled substance[or a
Schedule III controlled substance containing hydrocodone] to a human
patient, a physician shall:

††††† (a) Obtain a medical history and conduct
a physical or mental health examination of the patient, as appropriate to the
patientís medical complaint, and document the information in the patientís
medical record;

††††† (b) Query KASPER for all available data
on the patient for the twelve (12) month period immediately preceding the patient
encounter and appropriately utilize that data in the evaluation and treatment
of the patient;

††††† (c) Make a written plan stating the
objectives of the treatment and further diagnostic examinations required;

††††† (d) Discuss the risks and benefits of the
use of controlled substances with the patient, the patientís parent if the
patient is an unemancipated minor child, or the patientís legal guardian or
health care surrogate, including the risk of tolerance and drug dependence; and

††††† (e) Obtain written consent for the
treatment.

††††† (2) In addition to the other standards
established in this administrative regulation, for purposes of treating pain as
or related to an acute medical condition, a physician shall not prescribe more
than a three (3) day supply of a Schedule II controlled substance, unless the
physician determines that more than a three (3) day supply is medically
necessary and the physician documents the acute medical condition and lack of
alternative medical treatment options to justify the amount of the controlled
substance prescribed.

††††† (3)(a) In addition to the other
standards established in this administrative regulation, a physician
prescribing or dispensing additional amounts of a Schedule II controlled
substance [or a Schedule III controlled substance containing hydrocodone]for
the same medical complaint and related symptoms shall:

††††† 1. Review, at reasonable intervals based
on the patientís individual circumstances and course of treatment, the plan of
care;

††††† 2. Provide to the patient any new
information about the treatment; and

††††† 3. Modify or terminate the treatment as
appropriate.

††††† (b) If the course of treatment extends
beyond three (3) months, the physician shall:

††††† 1. Query KASPER no less than once every
three (3) months for all available data on the patient for the twelve (12)
month period immediately preceding the query; and

††††† 2. Review that data before issuing any
new prescription or refills for the patient for any Schedule II controlled
substance[or a Schedule III controlled substance containing hydrocodone].

††††† (4)[(3)] To the extent not
already required by the standards established in this administrative
regulation, for each patient for whom a physician prescribes or dispenses a Schedule
II controlled substance[or a Schedule III controlled substance containing
hydrocodone], the physician shall keep accurate, readily accessible, and
complete medical records which include, as appropriate:

††††† (a) Medical history and physical or
mental health examination;

††††† (b) Diagnostic, therapeutic, and
laboratory results;

††††† (c) Evaluations and consultations;

††††† (d) Treatment objectives;

††††† (e) Discussion of risk, benefits, and
limitations of treatments;

††††† (a) A physician prescribing or
administering that controlled substance immediately prior to, during, or within
the fourteen (14) days following a major surgery or significant trauma,
being any[an] operative or invasive procedure or a delivery, if
the prescribing or administering is medically related to the operative or
invasive procedure or delivery and the medication usage does not extend beyond
the fourteen (14) days; or

††††† (b) A physician prescribing or dispensing
that controlled substance:

††††† 1. For administration in a hospital or
long-term-care facility if the hospital or long-term-care facility with an
institutional account, or a physician in those hospitals or facilities if no
institutional account exists, queries KASPER for all available data on the
patient or resident for the twelve (12) month period immediately preceding the
query, within twelve (12) hours of the patientís or residentís admission, and
places a copy of the query in the patientís or residentís medical records for
use during the duration of the patientís stay at the facility;

††††† 2. As part of a narcotic treatment
program licensed by the Cabinet for Health and Family Services;

††††† 3. As part of the patientís
hospice or end-of-life treatment;

††††† 4.[3.] For the treatment of
pain associated with cancer or with the treatment of cancer;

††††† 5.[4.] In a single dose to
relieve the anxiety, pain, or discomfort experienced by a patient submitting to
a diagnostic test or procedure;

††††† 6.[5.] Within seven (7)
days of an initial prescribing or dispensing under subsection (1) of this
section if the prescribing or dispensing:

††††† a. Is done as a substitute for the
initial prescribing or dispensing;

††††† b. Cancels any refills for the initial
prescription; and

††††† c. Requires the patient to dispose of any
remaining unconsumed medication;

††††† 7.[6.] Within ninety (90)
days of an initial prescribing or dispensing under subsection (1) of this
section if the prescribing or dispensing is done by another physician in the
same practice or in an existing coverage arrangement, if done for the same
patient for the same medical condition; or

††††† 8.[7.] To a research
subject enrolled in a research protocol approved by an institutional review
board that has an active federalwide assurance number from the United States
Department for Health and Human Services, Office for Human Research Protections
if the research involves single, double, or triple blind drug administration or
is additionally covered by a certificate of confidentiality from the National
Institutes of Health.

††††† Section 10. Violations. (1) Any
violation of the professional standards established in this administrative
regulation shall constitute a violation of KRS 311.595(12) and (9), which may
result in the imposition of disciplinary sanctions by the board, pursuant to
KRS 311.595.

††††† (2) Each violation of the professional
standards established in this administrative regulation shall be established by
expert testimony by one (1) or more physicians retained by the board, following
a review of the licenseeís patient records and other available information
including KASPER reports.

RANDEL C. GIBSON, D.O., President

††††† APPROVED BY AGENCY: June 26, 2017

††††† FILED WITH LRC: June 29, 2017 at 11 a.m.

††††† PUBLIC HEARING AND PUBLIC COMMENT PERIOD:
A public hearing on this administrative regulation shall be held on August 28,
2017 at 10:00 a.m., at the offices of the Kentucky Board of Medical Licensure,
310 Whittington Parkway, Suite 1B, Louisville, Kentucky 40222. Individuals
interested in being heard at this hearing shall notify this agency in writing
by August 21, 2017, five (5) workdays prior to the hearing, of their intent to
attend. If no notification of intent to attend the hearing was received by that
date, the hearing may be cancelled. This hearing will not be transcribed unless
a written request for a transcript is made. If you do not wish to be heard at
the public hearing, you may submit written comments on the proposed
administrative regulation. Written comments shall be accepted until August 31,
2017. Send written notification of intent to be heard at the public hearing or
written comments on the proposed administrative regulation to the contact
person.

††††† (a) What this administrative regulation
does: This administrative regulation establishes professional standards for
prescribing and dispensing controlled substances in the Commonwealth of
Kentucky.

††††† (b) The necessity of this administrative
regulation: It is necessary to promulgate this regulation to establish
professional standards for prescribing and dispensing controlled substances the
Commonwealth of Kentucky.

††††† (c) How this administrative regulation
conforms to the content of the authorizing statutes: This administrative
regulation acts specifically to establish the professional standards for
prescribing and dispensing controlled substances in the Commonwealth of
Kentucky.

††††† (d) How this administrative regulation
currently assists or will assist in the effective administration of the
statutes: This administrative regulation acts specifically to establish the
professional standards for prescribing and dispensing controlled substances in
the Commonwealth of Kentucky.

††††† (2) If this is an amendment to an
existing administrative regulation, provide a brief summary of:

††††† (a) How the amendment will change this
existing administrative regulation: This administrative regulation amendment
clarifies the professional standard for titration of controlled substances
consistent with the 2016 Centers for Disease Control and Prevention Guideline
for the Prescribing of Opioids for Chronic Pain and establishes the
professional standard of a 3-day prescribing limit on Schedule II controlled
substances for acute pain in conformity with the 2017 General Assemblyís
enactment of HB 333.

††††† (b) The necessity of the amendment to
this administrative regulation: It was necessary to amend the regulation in
order to clarify the professional standard for titration of controlled
substances consistent with the 2016 Centers for Disease Control and Prevention
Guideline for the Prescribing of Opioids for Chronic Pain and to and
establishes the professional standard of a 3-day prescribing limit on Schedule
II controlled substances for acute pain in conformity with the 2017 General
Assemblyís enactment of HB 333.

††††† (c) How the amendment conforms to the
content of the authorizing statutes: This amended regulation acts specifically
to further clarify the professional standards for prescribing and dispensing
controlled substances in the Commonwealth of Kentucky.

††††† (d) How the amendment will assist in the
effective administration of the statutes: This amended regulation acts
specifically to further clarify the professional standards for prescribing and
dispensing controlled substances in the Commonwealth of Kentucky.

††††† (3) List the type and number of
individuals, businesses, organizations, or state and local governments affected
by this administrative regulation: This amendment will affect all physicians
licensed in the Commonwealth of Kentucky who prescribe or dispense controlled
substances.

††††† (4) Provide an analysis of how the
entities identified in question (3) will be impacted by either the
implementation of this administrative regulation, if new, or by the change, if
it is an amendment, including:

††††† (a) List the actions that each of the
regulated entities identified in question (3) will have to take to comply with
this administrative regulation or amendment: Physicians will be required to
follow the professional standards for prescribing and dispensing controlled
substances in the Commonwealth of Kentucky.

††††† (b) In complying with this administrative
regulation or amendment, how much will it cost each of the entities identified
in question (3): There is no cost associated with the requirements of this
administrative regulation known to the Board.

††††† (c) As a result of compliance, what
benefits will accrue to the entities identified in question (3): Benefits to
the physician including having professional standards for prescribing or
dispensing controlled substances which will help curb the prescription drug
epidemic in the Commonwealth of Kentucky.

††††† (5) Provide an estimate of how much it
will cost to implement this administrative regulation:

††††† (a) Initially: None.

††††† (b) On a continuing basis: None.

††††† (6) What is the source of the funding to
be used for the implementation and enforcement of this administrative
regulation: None.

††††† (7) Provide an assessment of whether an
increase in fees or funding will be necessary to implement this administrative
regulation, if new, or by the change, if it is an amendment: No increase of
fees or funding will be necessary.

††††† (8) State whether or not this
administrative regulation establishes any fees or directly or indirectly
increases any fees: This administrative regulation does not establish any fees
nor does it directly or indirectly increase any fees.

††††† (9) TIERING: Is tiering applied? Tiering
was not appropriate in this administrative regulation because the
administrative regulation applies equally to all individuals regulated by it.

FISCAL NOTE ON STATE OR
LOCAL GOVERNMENT

††††† (1) What units, parts or divisions of
state or local government (including cities, counties, fire departments, or
school districts) will be impacted by this administrative regulation? The
Kentucky Board of Medical Licensure will be impacted by this administrative
regulation.

††††† (2) Identify each state or federal
statute or federal regulation that requires or authorizes the action taken by the
administrative regulation: KRS 311.565(1)(a) and KRS 218A.205(3)

††††† (3) Estimate the effect of this
administrative regulation on the expenditures and revenues of a state or local
government agency (including cities, counties, fire departments, or school
districts) for the first full year the administrative regulation is to be in
effect. None

††††† (a) How much revenue will this
administrative regulation generate for the state or local government (including
cities, counties, fire departments, or school districts) for the first year? None

††††† (b) How much revenue will this
administrative regulation generate for the state or local government (including
cities, counties, fire departments, or school districts) for subsequent years? None

††††† (c) How much will it cost to administer
this program for the first year? None

††††† (d) How much will it cost to administer
this program for subsequent years? None

††††† Note: If specific dollar estimates cannot
be determined, provide a brief narrative to explain the fiscal impact of the
administrative regulation.